Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
138 participants
OBSERVATIONAL
2018-01-12
2020-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TPD RAMWare Download
Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data.
TPD RAMWare
TPD RAMWare injected into enrolled subject's Implantable cardioverter-defibrillator (ICD) device for use
Interventions
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TPD RAMWare
TPD RAMWare injected into enrolled subject's Implantable cardioverter-defibrillator (ICD) device for use
Eligibility Criteria
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Inclusion Criteria
* Secondary Prevention or,
* Primary Prevention and has had a device treated VT/VF or a device recorded episode of sustained VT/VF
* Subject is ≥ 18 years old
* Subject has previously documented history of VT/VF
* Subject must be willing and able to use Medtronic CareLink network monitoring system
* Subject provides signed and dated authorization and/or consent per institution and local requirements
* Subject is willing and able to comply with the protocol
Exclusion Criteria
* Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
* Subject has chronic AF
* Subject has inherited disorders of ion transport mechanisms that predispose the subject to sudden death ("Channelopathies"): Long QT and Brugada Syndromes
* Subject with multiple implanted active devices that may cause an interruption of a transmission of device data to CareLink
* Subject has active electronic medical device other than an ICD
* Subject requires more than 25% atrial or ventricular pacing
* Subject has medical conditions that would limit study participation (per investigator judgment)
* Subject has projected life expectancy of less than 1 year
* Subject is pregnant or plans to be pregnant over the next year (females of child-bearing potential must have a negative pregnancy test within one week of enrollment and must practice a reliable form of birth control while enrolled in the study)
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Brown
Role: STUDY_DIRECTOR
Medtronic
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Iowa Heart Center
Des Moines, Iowa, United States
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States
Saint Lukes Hospital of Kansas City
Kansas City, Missouri, United States
Bryan Heart
Lincoln, Nebraska, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Cape Fear Heart Associates
Wilmington, North Carolina, United States
Mount Carmel East
Columbus, Ohio, United States
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Centennial Heart Cardiovascular Consultants
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Princess Margaret Hospital
Hong Kong, , Hong Kong
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TPD Study
Identifier Type: -
Identifier Source: org_study_id